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Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)
Description
This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.\~30 million people in the US have chronic kidney disease (CKD) and are at 5-15 fold greater risk of cardiovascular (CV) disease and mortality. A major factor contributing to increased CV risk in these patients is chronic elevation of sympathetic nervous system (SNS) activity. New therapeutic strategies to safely and effectively ameliorate SNS over-activity are of paramount importance to improve clinical outcomes in this highly prevalent and high-risk patient population. This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-inhibitory effects of mind
Trial Eligibility
Inclusion Criteria: * stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation * stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months) Exclusion Criteria: * severe CKD (eGFR\<15 cc/min) * diabetic neuropathy * autonomic dysfunction * any serious disease that might influence survival * anemia with hemoglobin \<10 g/dL * treatment with central α-agonists or monoamine oxidase (MAO) inhibitors * myocardial infarction or cerebrovascular accident within the past 6 months * uncontrolled hypertension (BP≥170/100 mm Hg) * low BP (BP\<100/50 mm Hg) * bradycardia (HR\<55 beats/min) * ongoing drug or alcohol abuse (defined as \>2 drinks/day in men, and \>1 drink/day in women) * surgery within the past 3 months * adjustment of antihypertensive medications within the past month * pregnancy or plans to become pregnant * psychosis * suicidal ideation * implanted electronic or metallic device such as a pacemaker * implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck * carotid atherosclerosis * concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit.
Study Info
Organization
Emory University
Primary Outcome
Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)
Interventions
Locations Recruiting
Atlanta VA Medical Center
United States, Georgia, Atlanta
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